Cleared Traditional

K173942 - Blue Non Sterile powder free Nitrile Ex...

K173942 is an FDA 510(k) clearance for Blue Non Sterile powder free Nitrile Ex..., manufactured by Central Medicare Sdn Bhd. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K173942 · Central Medicare Sdn Bhd · General Hospital
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Mar 2018
Decision
69d
Days
Class 1
Risk

K173942 is an FDA 510(k) clearance for the Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with C.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Central Medicare Sdn Bhd (Teluk Intan, MY). The FDA issued a Cleared decision on March 5, 2018 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Central Medicare Sdn Bhd devices

FDA 510(k) Submission Details - K173942

510(k) Number K173942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2017
Decision Date March 05, 2018
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

LZC Device Classification - Class 1, General Controls

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZC Medical Glove, Specialty

All 50
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K173942.
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K180646 · Halyard Health · Jun 2018
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K180476 · Comfort Rubber Gloves Industries Sdn. Bhd. · May 2018
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K172864 · Maxter Glove Manufacturing Sdn Bhd · May 2018
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
K162186 · Brightway Holdings Sdn. Bhd. · Mar 2017
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K141982 · Wrp Asia Pacific Sdn. Bhd. · Feb 2015
POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
K121811 · Shen Wei (Usa), Inc. · Nov 2012